tDCS and Lower Limb Performance in Stroke

NCT ID: NCT06463795

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-01-31

Brief Summary

Lower limb rehabilitation is especially important, as the simple act of regaining the ability to walk has subsequent effects on the ability to engage in activities of daily living .So, this study will contribute in describing the management of lower limb motor recovery along with the therapeutic intervention (MRP) with tDCS (anodal stimulation). This study aims to address some of the drawbacks observed in previous studies like allocation concealment, small sample size due to drop outs, short term effects of tDCS and experimental designs as well.

Detailed Description

Transcranial Direct Current Stimulation (tDCS) appears to be an intriguing adjuvant for stroke neurorehabilitation, though there are many other methods available. Depending on the polarity used, tDCS alters cortical excitability when electrodes applied over the motor cortex area (M1) to be stimulated, and the cathode above the contralateral eye (Orbital area), tDCS (thus termed anodal) increases cortical excitability. It is easy to use, safe and has minimal side effects like a sensation of itching, post-stimulation headache and sometimes mild nausea may experience. Numerous research indicates that cortical activity rises in conjunction with gait. According to a number of studies, corticospinal neuron activity either parallels or possibly even partially regulates the activity of spinal motor neurons during walking. There exist various techniques for implementing transcranial direct current stimulation in conjunction with multiple supplementary therapies.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tDCS Group

Electrode placement: Anodal electrode placed over primary motor cortex area (M1) while the cathode placed over contralateral orbit.

Duration of 20 minutes with intensity of 2mA, ramping up and down at 8 seconds. the density of 0.07 C/cm2 for 3 days/week for 8 weeks

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

active anodal tDCS

Sham Group

Electrode placement: Anodal electrode placed over primary motor cortex area (M1) while the cathode placed over contralateral orbit.

Duration of 20 minutes with intensity of 0.5mA, ramping up and down at 150 and 30 seconds respectively. There will be brief stimulation period of 3-5% active session duration the density of 0.07 C/cm2 for 3 days/week for 8 weeks

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: DEVICE

sham anodal tDCS

Interventions

tDCS

active anodal tDCS

Intervention Type: DEVICE

Sham tDCS

sham anodal tDCS

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Stroke for more than 6 months.
• National Institutes of Health Stroke Scale (NIHSS) for severity level (Mild (1-4), Moderate (5-15), Moderate to Severe (16-20), Severe (21-42)

Exclusion Criteria

• Epilepsy
• Scalp injury/ skin lesion e.g. psoriasis or eczema etc.
• Patient with lower limb amputation or any MSK/neurological disorder that limit the LE function
• Implanted medical devices including intracranial electrodes, surgical clips, shrapnel or a pacemaker

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mirza Obaid Baig, MSPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

References

Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

Reference Type: BACKGROUND

PMID: 33175411 (View on PubMed)

Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.

Reference Type: BACKGROUND

PMID: 34695300 (View on PubMed)

Bai X, Guo Z, He L, Ren L, McClure MA, Mu Q. Different Therapeutic Effects of Transcranial Direct Current Stimulation on Upper and Lower Limb Recovery of Stroke Patients with Motor Dysfunction: A Meta-Analysis. Neural Plast. 2019 Nov 16;2019:1372138. doi: 10.1155/2019/1372138. eCollection 2019.

Reference Type: BACKGROUND

PMID: 31827495 (View on PubMed)

Other Identifiers

REC01898 Saira Muzaffar Shah

Identifier Type: -

Identifier Source: org_study_id